Mobile Phone-administered Triage Tool to Followup on Discharged Trauma Patients

NCT03805646 | Completed Results

• 1 other identifier: GRANT12763845
• Study Type: interventional
• Target: 3,990
• Locations: 1 country
• Sites: 4

Brief Summary

After being admitted to and then discharged from a hospital in Cameroon for having experienced an injury, there is no established way for the health system to check in on how the discharged person is doing. The investigators have developed a set of questions with the hope that asking these questions--over the phone--to those who have been discharged from the hospital will allow them to determine which post-discharge patients would benefit from further care. The investigators believe that asking these questions over the phone is a good way of determining which post-discharge trauma patients would benefit from further care.

Conditions

Wounds and Injury

Keywords

Aftercare; Telemedicine; Africa South of the Sahara

Outcome Measures

Primary Outcomes (10)

• Proportion of Successful Contacts

  The number of successful contacts will be divided by the total number of contacts. A "successful" contact is when an enrolled patient answered the phone, and consented to the research assistant administering the questionnaire(s) planned for that phone call.

  2 weeks after enrollment

• Median Number of Attempts Required to Achieve a Successful Contact

  This is the median number of call attempts made until a research assistant is able to successfully administer the questionnaire(s) planned for that phone call.

  2 weeks after enrollment

• Median Cost Associated With Personnel Time

  This measure is median monthly costs incurred to pay the research assistant for the time s/he spends making the required phone calls per patient.

  At the end of the study (2 weeks after the 2-year intervention phase (extended due to COVID))

• Median Cost Associated With Telephone Time

  This measure is the median costs incurred to make phone calls per patient in each study phase.

  At the end of the study (2 weeks after the 2-year intervention phase (extended due to COVID))

• Telephone Triage Tool Administration Time

  This measure will be calculated based on how much time it takes to administer the telephone triage tool.

  After administration of the telephone triage tool (i.e. about 2 weeks after enrollment)

• Physician Assessment of Whether a Patient Would Benefit From Further Services

  This is a binary measure. After a physician examines a participant, s/he will determine whether s/he thinks the participant would benefit from further services (including additional follow-up care, and/or diagnostic or therapeutic interventions).

  Immediately after the physician administers the physical exam (i.e. about 3 weeks after enrollment)

• Physician Assessment of Whether a Patient Was at Moderate to High Risk for a Poor Outcome (HR) Without Additional Intervention

  After a physician examines a participant, s/he will determine whether s/he thinks the participant is at low, moderate or high risk for a poor outcome (HR) without additional intervention using subjective clinical assessment.

  Immediately after the physician administers the physical exam (i.e. about 3 weeks after enrollment)

• Triage Risk Score (TRS)

  To develop a sensitive model capable of risk stratifying triaged patients for high risk (HR), all candidate questions from the telephone triage tool found to associate with HR on univariate regression were weighted by their predictive coefficient and added to generate a triage risk score (TRS) ranging from a minimum score of 0 (lowest risk) to a maximum possible score of 43.9 (highest risk). Triage Risk Score (TRS) less than or equal to 1.3 (1st quartile) was designated as low risk, TRS 1.4 to 4.0 (2nd \& 3rd quartile) as moderate risk, and TRS greater than or equal to 4.1 (fourth quartile) as high risk.

  At the end of intervention phase (about 1 year after enrollment).

• Acceptability Score of Mobile Phones as a Follow-up Tool

  This is a numerical measure that represents the sum of the positive responses that participants give to each question that assesses the acceptability of mobile phones as a follow-up tool. The scale for the acceptability score of mobile phones as a follow-up tool ranges from 0 to 6, where 0 means the participant's responses indicate the participant believes mobile phones are definitely not an acceptable follow-up tool and 6 means the participant's responses indicate the participant believes mobile phones are definitely an acceptable follow-up tool.

  2 weeks after enrollment

• Proportion of Injured Patients Who Seek Clinical Follow-up Evaluation

  This will be calculated as follows: The denominator will be the number of discharged trauma patients enrolled in the study. The numerator will be the number of discharged trauma patients enrolled in the study who seek any clinical follow-up evaluation at the 2 weeks post-discharge phonecall.

  After the 2week post-discharge phonecall.

Secondary Outcomes (4)

• Glasgow Outcomes Scale-Extended (GOSE) Disability Level

  At the 2week post-discharge telephone phonecall.

• Economic Consequences of Injury: Did it Become More Difficult for the Family to Afford Expenses Such as Food and Rent?

  At the 2week post-discharge telephone phonecall.

• Economic Consequences of Injury: Did the Family Spend Saved Money?

  At the 2week post-discharge telephone phonecall.

• Economic Consequences of Injury: Did the Family Borrow Money?

  At the 2week post-discharge telephone phonecall.

Study Arms (2)

No Mobile Phone-administered Triage Tool

NO INTERVENTION

For each hospital site: Baseline data will be collected for six months. \*\*This extended beyond 6 months due to the COVID pandemic\*\*\*

Mobile Phone-administered Triage Tool

EXPERIMENTAL

For each hospital site: After the first six months of baseline data collection, the mobile phone-administered triage tool (or "Mobile Phone-based Triage Tool") will be implemented for a year. \*\*This extended beyond 1 year due to the COVID pandemic\*\*\*

Other: Mobile Phone-based Triage Tool

Interventions

Mobile Phone-based Triage Tool OTHER

The proposed intervention is a mobile phone-administered survey. Participants that have been admitted to participating hospitals for treatment of injury will be contacted by mobile phone approximately two weeks after discharge. A seven-question survey will be administered over the phone to each participant. Cross-validation with a separately administered in-person physical exam will be performed to assess the survey tool's prediction of who needs further care for treatment of their injury.

Mobile Phone-administered Triage Tool

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of Buea: collaborator

Study Sites (4)

Laquintinie Hospital

Douala, Cameroon

Location

Edea Regional Hospital

Edéa, Cameroon

Location

Limbé Regional Referral Hospital

Limbe, Cameroon

Location

Pouma Catholic Hospital

Pouma, Cameroon

Location

MeSH Terms

Conditions

Wounds and Injuries

Limitations and Caveats

Early in the COVID pandemic due to restrictions in Cameroon and to ensure safety of participants, changes were made such as pausing intervention phase where patients were asked to return to the hospital for a physician exam to cross-validate the telephone triage tool and reverting to baseline. The step-wedge design was also scrapped as this was disrupted by the pause. Low recruitment numbers in COVID also accounted for the intervention phase to be extended beyond the pre-specified timeline.

Results Point of Contact

• Title: Dr. Catherine Juillard
• Organization: University of California Los Angeles

cjuillard@mednet.ucla.edu

310-267-9609

Study Officials

• Catherine Juillard, MD, MPH

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor In-Residence

Model Details: None of the interventional study model categories aptly describe the study. The step-wedge design of the study means each site has historical controls; the only thing determining whether an individual receives the intervention or not is time (that is, whether the hospital site s/he was admitted to happens to be in the pre-intervention/baseline data collection phase or the intervention phase).

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 16, 2019
• Study Start: August 5, 2019
• Primary Completion: August 31, 2022
• Study Completion: September 14, 2022
• Last Updated: November 27, 2024
• Results First Posted: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)